HealthyPhase 1NCT01737996

Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects

A Phase 1 study testing BI 207127 + faldaprevir in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 207127 + faldaprevir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteGermany
Study dates: Nov 2012to Mar 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1. healthy male and female subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1241.35.1 Boehringer Ingelheim Investigational Site
Mannheim

Other trials in Germany

About this study

Official title: An Open-label, Multiple Dose Study to Assess Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID Administered Orally for 9 Days (Part 1) and Multiple Doses of BI 207127 Combined With Faldaprevir Administered Orally for 16 Days (Part 2) in Healthy Male and Female Subjects

Conditions: Healthy
Being tested: BI 207127 + faldaprevir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 207127 + faldaprevirDrug
fixed dose combination

Study groups in NCT01737996
Study group	Role	What they receive
All patients	Experimental	For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir Receives: Drug: BI 207127 + faldaprevir

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Healthy Subjects With AEs (Multiple Rising Dose Part)
Number of healthy subjects with any adverse event (AE) during the on-treatment period.
Measured: From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)
Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.
Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)
Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)
Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)
Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
CD 6168 is a major metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)
Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16.
CD 6168 is a major metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)
Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
CD 6168 is a major metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)
Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
BI 208333 is a major metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)
Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16.
BI 208333 is a major metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)
Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
BI 208333 is a major metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)
Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)
Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16.
CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)
Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)
Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)
Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.
Measured: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning.

Secondary outcomes (8)

AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)
Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.
Measured: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)
Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9.
Measured: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)
Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.
CD 6168 is a major metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)
Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9.
CD 6168 is a major metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)
Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.
BI 208333 is a major metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)
Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9.
BI 208333 is a major metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)
Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.
CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)
Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9.
CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Measured: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Mar 2013

First posted30 Nov 2012 (estimated)
Study startNov 2012
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01737996
Sponsor's protocol ID: 1241.35
Other IDs: 2012-003697-10
Status last verified: Mar 2016
First submitted: 26 Nov 2012
Last updated: 8 Apr 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multiple Dose Study to Assess Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID Administered Orally for 9 Days (Part 1) and Multiple Doses of BI 207127 Combined With Faldaprevir Administered Orally for 16 Days (Part 2) in Healthy Male and Female Subjects
ClinicalTrials.gov ID: NCT01737996
Acronym / sponsor ID: 1241.35
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 30 Nov 2012 (estimated)
Results: Posted 8 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All patients	Experimental	Drug: BI 207127 + faldaprevirFor the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. healthy male and female subjects

Key exclusion criteria (1 listed)

1. Any relevant deviation from healthy conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 207127 + faldaprevirfixed dose combination	Drug	All patients

Primary outcome

Number of Healthy Subjects With AEs (Multiple Rising Dose Part)
Time frame: From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Number of healthy subjects with any adverse event (AE) during the on-treatment period.
AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.
Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.
Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.
C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir.
Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir.
C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir.
AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir.
Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir.
C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir.
C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir.
AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.
Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)
Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning.
Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.

8 secondary outcomes

AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)
Time frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)
Time frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)
Time frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)
Time frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)
Time frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)
Time frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)
Time frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.
Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)
Time frame: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.

Results and safety

Results posted to the registry on 8 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
400 mg Deleobuvir	8	8
600 mg Deleobuvir	8	7
600 mg Deleobuvir + 120 mg Faldaprevir	16	14

Primary outcome: Number of Healthy Subjects With AEs (Multiple Rising Dose Part)

Time frame: From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration). Number. Unit: participants

Measure	400 mg Deleobuvir n = 8	600 mg Deleobuvir n = 8
Value	6	5

Population analysed: Treated Set. The treated set included all subjects who were documented to have taken at least 1 dose of study medication.

Primary outcome: AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)

Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	600 mg Deleobuvir + 120 mg Faldaprevir n = 14
AUC(0-12h) on Day 1	37500 (49.4)
AUC(0-12h,ss) on Day 16	51400 (57.2)

Population analysed: PKS. The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least 1 observation for at least 1 pharmacokinetic endpoint without important protocol violations relevant for the statistical evaluation of pharmacokinetic endpoints. Including patients with available data.

Primary outcome: Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)

Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	600 mg Deleobuvir + 120 mg Faldaprevir n = 15
Cmax on Day 1	6930 (47.9)
Cmax,ss on Day 16 (N=14)	9710 (43.3)

Population analysed: PKS including patients with available data.

Primary outcome: C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)

Time frame: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	600 mg Deleobuvir + 120 mg Faldaprevir n = 14
C(12h) on Day 1	1090 (69.3)
C(12h,ss) on Day 16	1000 (85.9)

Population analysed: PKS including patients with available data.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
400 mg Deleobuvir	0 of 8 (0%)	6 of 8 (75%)	Not reported
600 mg Deleobuvir	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
600 mg Deleobuvir + 120 mg Faldaprevir	0 of 16 (0%)	9 of 16 (56.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 207127 + faldaprevir in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Healthy Subjects With AEs (Multiple Rising Dose Part) (time frame: From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01737996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016.